Monday, June 25, 2012

Real Wall Street, Please Meet Elite

While Jerry Treppel does not usually appear concerned with the day-to-day PPS of ELTP, its investors are suggesting that most promotional pieces like the news release that was put out by Wall Street PR (not Wall Street Journal, but it helps...) is the best way to attract new investors.  A higher PPS might even legitimize ELTP in the eyes of institutional investors in the wake of the latest company headlines: 
Last month, Elite Pharmaceuticals was awarded U.S Patent No. 8,182,836 clearing the way for them to begin producing a time-release opiate that prevents users from abusing their product. However, it was today’s announcement of a $500,000 bridge loan that saw the stock gain nearly 15% on a day that saw the biggest across the board stock price drop in three weeks.
Investors like articles like this because the company's own PR about receiving the 216 patent was far from a sales pitch.  However, the information reeks of legitimacy as IHUB board wars continue to be waged.
The fluff piece further addressed the latest official loan PR by stating:
Jerry Treppel, Elite’s CEO, has agreed to provide a line of credit not to exceed $500,000 to the company he runs. The loan is being made in order for Elite to accelerate its commercialization of its existing products and the development of new products that await patent approval. The loan has been granted at a 10% annual interest rate with interest payments to be paid quarterly beginning in three months time.
The company has already begun purchasing equipment and hiring staff in anticipation of the finalization of the loan terms.


Meanwhile, the IHUBBERS are scratching at each other's eyes with both sides (basher and non-basher) making their claims.  On IHUB, where boundless "pumping" is the signature name to the game, a few bashers refuse to back down. 

Lasers, (on fire of late) says:

NDA505(b)(2)is approval request of a new drug dependent on a Commercial drug approved by the FDA.

You have been given links to NDA505(b)(2)in prior posts.

Embeda ALO-01 went this route by claiming Purdue approval OxyContin is similar. Pfizer/King ALO-01 was granted a NDA505(b)(2)approval in 2009.

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022321s000ltr.pdf

Pfizer is applying the NDA505(b)(2)route to ALO-02. Notice the comparison by including Purdue OxyContin in the public wording.

http://clinicaltrials.gov/ct2/show/NCT01557257

Drug: OxyContin

The problem is that in 2010 Purdue's OxyContin OC (agonist/antagonist)was replaced as OxyContin OP (hard shell agonist only). Purdue had continuing manufacturing problems with their 1-bead OxyContin OC and after several recalls gave up on it.

http://www.purduepharma.com/news-media/2010/04/statement-of-purdue-pharma-l-p-regarding-fdas-approval-of-reformulated-oxycontin-oxycodone-hcl-controlled-release-tablets/

Both 1-bead manufacturing techs Pfizer's Embeda ALO-01 and Purdue's OxyContin OC have manufacturing problems. OxyContin OC has been taken off the market in 2010 and Embeda ALO-01 has been recalled/stopped since 2010.

Until Pfizer solves the manufacturing problems for ALO-01, it cannot be expected that the FDA would approve 1-bead ALO-02! 

This was rebutted by Dr Low: 

No, a 505b2 is available only if the active ingredient is the same. The Embeda approval did not rely on Purdue's oxycontin in any way. It is totally illogical to try to link the AL)-02 approval to any manufacturing issues that Purdue may or may not be having


As the pro-ELTPs hissed, Lasers was busy brainstorming, and fired off another interesting speculative notion:


How about this as a speculation?

If the partner for ELI-216 Phase III trial is Watson/Actavis. Watson foots the cost for the ELI-216 Phase III and in return Watson and Elite structure a contract for Elite to apply it to Watson Morphine Sulphate opioid product that is in competition with Pfizer/King Embeda.

Elite's new 15,000 sq ft manufacturing space is idle.

Elite keeps 100% of the profits for ELI-216 oxycodone/naltrexone and in turn JVs with Watson to manufacture Watson's Morphine opioid at Elite's NJ 30,000 sq ft facilities.

Expected cost for Elite's FDA 300 person ELI-216 Phase III trial is $7 mil. Watson funds it and Watson gets $7 mil back many times over with the profits from the successful marketing of its new Morphine agonist/antagonist ELI-216 2-bead product manufactured by Elite for Watson.


Ongoing concern/speculation over who will finance ELTP and their products is surging.  There has been significant interest during the last two years from various companies like Actavis, Socius, HlTK, EPIC, TPN and TAGI (as noted by poster Tangerine).  July 1st is around the corner, stay tuned for more!



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